Process Alliance is a leading engineering consultancy firm dedicated to delivering innovative solutions in engineering, automation, manufacturing services, and medical devices. With a commitment to being a better model of problem solving, we have been at the forefront of providing cutting-edge engineering services to clients across the life science industry. Our team of experts thrives on solving complex challenges and driving technological advancements to meet the evolving needs of our clients.
Overview:
We're hiring a deviation writer to join a pharmaceutical manufacturing team in Durham, North Carolina. This full-time, on-site role is ideal for an early-career scientist or engineer with 1-2 years of experience in GMP manufacturing or quality support.
Key Responsibilities:
Write detailed deviation reports, documenting investigations in compliance with GMP standards
Collaborate with cross-functional teams (QA, manufacturing, QC, engineering) to gather data and support root cause analysis
Manage and document change controls, including gathering justification, impact assessments, approvals, and closure
Ensure timely closure of deviations and support CAPA documentation as needed
Participate in deviation trending and reporting to drive continuous improvement
Qualifications:
Bachelor's degree in a scientific or engineering or related field
1-2 years of experience in the pharmaceutical industry
Experience writing or supporting GMP deviation investigations preferred
Packaging experience is a plus
Quality Control Lab experience is a plus but not required
Strong analytical and writing skills
Familiarity with quality systems is a plus
About Our Culture:
At Process Alliance, we strive to be a better model for how problems are solved, and solutions are delivered. We believe in providing a supportive and inclusive work environment where employees can thrive both personally and professionally. Join our team and be part of a company that is shaping the future of engineering solutions.
Learn more about us:
Visit our website at *********************** to explore our projects, expertise, and the impact we make in the engineering and consultancy space.
Process Alliance is an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences.
$52k-90k yearly est. 21h ago
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Principal Clinical Content- Physician - UpToDate , Physician Editor (Cardiology)
Wolters Kluwer 4.7
Editor job in Raleigh, NC
**LOCATION:** U.S. locations - remote/hybrid. Candidates within commuting distance of a Wolters Kluwer office will be considered for hybrid employment. Candidates not within commuting distances will be considered for remote employment. The Physician Editor (Cardiology) position requires an 80 to 90% FTE commitment for editorial work, a broad understanding of clinical issues, and an interest in analyzing the literature. For the right person, this is a unique opportunity to impact the practice of medicine throughout the United States and around the world. Physician Editors ensure that topics address the important clinical questions that arise when diagnosing or managing a specific disorder, present information clearly and succinctly, and provide evidence-based and actionable recommendations for care. Extensive editorial training is provided to help the editor learn critical skills for evaluating the literature and creating content in the UpToDate style. Training is overseen by at least two senior Physician Editors. All new topics are read and reviewed by the training editors until the new Physician Editor achieves a satisfactory level of independence.
You will be trained remotely and can work from anywhere in the United States. However, work hours should significantly overlap with standard work hours in the Eastern time zone to allow for regular interaction with other Physician Editors. Candidates with strong academic backgrounds are of particular interest. Editing requires 80 to 90% FTE. In the remaining 10 to 20% time, Physician Editors should continue patient care activities, using their clinical experience to help ensure the content of the program is maximally useful at the point of care. Thus, the position provides the opportunity to remain clinically active while spending most of your time crafting clear content, reviewing the literature, and discussing the impact of new research on clinical practice with our expert contributors.
**ESSENTIAL DUTIES & RESPONSIBILITIES:**
Our physician editors review and edit the new contributions from our external expert authors to make sure they address the questions that a practicing clinician might have. Topics must contain specific and actionable recommendations and describe the supporting evidence. Updating is an equally important component of the work and is usually initiated by the Physician Editor, who is responsible for monitoring the literature for new developments and identifying topics that need updating. Physician Editors also systematically review existing topics for clarity, completeness, and clinical relevance. This work is not done in isolation. UpToDate editors work closely with outside authors, section editors, editors-in-chief, and peer reviewers to ensure the material is accurate and free of bias. In addition, in-house editorial and graphics assistants work with the Physician Editors to produce and maintain each topic.
**QUALIFICATIONS**
**Required Education:**
- Medical Degree
- Board Certification/Eligibility in Cardiology
**Preferred Experience, Knowledge, and Abilities:**
- Clinical experience in an academic setting after residency
- A valid medical license in at least on U.S. state
- Impeccable communication skills: verbal, writing, and listening
- Ability to work collaboratively with colleagues at different skill levels
- Self-motivated, with excellent organizational and time management skills
- Ability to give and receive feedback effectively
- Interest in critical analysis of the medical literature (skills can be learned on the job)
- Ability to spend 80 to 90% of the work week on editorial work
- Interest in and ability to maintain clinical work (10 to 20%)
TRAVEL: Minimal - less than 5%
UpToDate (***************** is an electronic clinical decision support resource for physicians and patients that provides current medical information in a format accessible via computer, smartphone, or tablet. UpToDate is part of Wolters Kluwer Health, an international corporation that provides tools to assist professionals in health care, finance, and accounting. More than 850,000 clinicians in 164 countries and more than 90% of academic medical centers in the United States rely on UpToDate. Over 60 research studies confirm UpToDate's widespread usage and association with improved patient care and hospital performance, including reductions in length of stay, adverse complications, and mortality.
\#LI-remote
**Our Interview Practices**
_To maintain a fair and genuine hiring process, we kindly ask that all candidates participate in interviews without the assistance of AI tools or external prompts. Our interview process is designed to assess your individual skills, experiences, and communication style. We value authenticity and want to ensure we're getting to know you-not a digital assistant. To help maintain this integrity, we ask to remove virtual backgrounds and include in-person interviews in our hiring process. Please note that use of AI-generated responses or third-party support during interviews will be grounds for disqualification from the recruitment process._
_Applicants may be required to appear onsite at a Wolters Kluwer office as part of the recruitment process._
**Compensation:**
$172,100.00 - $307,450.00 USD
This role is eligible for Bonus.
_Compensation range listed is based on primary location of the position. Actual base salary offer is influenced by a wide array of factors including but not limited to skills, experience and actual hiring location. Your recruiter can share more information about the specific offer for the job location during the hiring process._
**Additional Information** **:**
Wolters Kluwer offers a wide variety of competitive benefits and programs to help meet your needs and balance your work and personal life, including but not limited to: Medical, Dental, & Vision Plans, 401(k), FSA/HSA, Commuter Benefits, Tuition Assistance Plan, Vacation and Sick Time, and Paid Parental Leave. Full details of our benefits are available upon request.
EQUAL EMPLOYMENT OPPORTUNITY Wolters Kluwer U. S. Corporation and all of its subsidiaries, divisions and customer/business units is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
$46k-61k yearly est. 60d+ ago
Senior Copywriter
Accenture 4.7
Editor job in Raleigh, NC
We are: Accenture Song is the world's largest tech-powered creative group. We accelerate growth and value for our clients through sustained customer relevance. Our capabilities span ideation to execution: growth, product and experience design; technology and experience platforms; creative, media and marketing strategy; and campaign, content and channel orchestration. With strong client relationships and deep industry expertise , we help our clients operate at the speed of culture through the unlimited potential of creativity, technology and intelligence-both human and artificial. Visit us at: **********************
You are:
We are searching for a Senior Copywriter who is passionate about their craft and eager to make an impact on the work we do. This individual is experienced within the creative industry and is comfortable with multiple medias-from interactive, to brand campaign, and digital content and has worked with a variety of clients, tones and voice styles and will ensure exceptional results . This position needs someone who is confident as an individual contributor, ready to jump in and take a leadership role when required and embraces collaboration to deliver the best concept and solutions. Our ideal candidate has a substantial portfolio of published creative work and professional writing experience. This person must thrive in a fast-paced work environment and enjoy working on numerous projects at once. But above all, this candidate is a strong writer who can easily adapt to different styles .
The work:
+ Write compelling and creative copy for a variety of platforms and lengths across the funnel-from big idea campaigns and TV spots to long form content eBooks and social media ads
+ Demonstrate excellent oral and written communication skills
+ Demonstrate excellent presentation skills; comfortable presenting and defending concepts and copy for both internal and client-facing meetings
+ Deliver assignments on time while consistently meeting Accenture Song quality standards
+ Demonstrate proficiency in copy style guidelines
+ Understand and appreciate the importance of strategy
+ Manage multiple clients and deliverables simultaneously with keen attention to craft and detail
+ Handle all facets of production and post-production with minimal supervision
+ Lead and own work, and formulate and develop disruptive ideas with minimal oversight or creative direction
+ Lead and mentor junior copywriters and ensure Accenture Song quality standards in all copy deliverables
Basic Qualifications:
+ At least 4 years of copywriting experience (B2B or B2C)
+ Minimum 2 of years agency or equivalent industry experience in the creative field across all media-including digital, social, film, longform content and print
+ Portfolio or samples of work demonstrating smart, strategic, disruptive and/or brand-building concepts and executions across multiple platforms.
Bonus points if you have:
+ Bachelor's degree in creative writing, journalism, advertising, marketing, or English
+ Excellent presentation skills/public speaking
+ Clear point of view on AI and the future of advertising
+ Natural storytelling skills
+ Ability to work and thrive in a highly collaborative environment with multidisciplinary cross-function teams.
+ Expertise in strategic brainstorming and campaign development
+ Experience in using GenAI as part of your workflow
+ Experience with Telecomm, Media and Technology (CMT) industry clients
+ Experience in scaled AOR engagements
+ Portfolio includes award-winning, industry-acclaimed work for craft and creativity ( OneShow , AD&D, Cannes, Webbys , Emmys, Andys, Effies , ADC)
+ Fluent in social media platforms and trends
Compensation at Accenture varies depending on a wide array of factors, which may include but are not limited to the specific office location, role, skill set, and level of experience. As required by local law, Accenture provides a reasonable range of compensation for roles that may be hired as set forth below.We accept applications on an on-going basis and there is no fixed deadline to apply.
Information on benefits is here. (************************************************************
Role Location Annual Salary Range
California $63,800 to $145,400
Cleveland $59,100 to $116,300
Colorado $63,800 to $125,600
District of Columbia $68,000 to $133,700
Illinois $59,100 to $125,600
Maryland $63,800 to $125,600
Massachusetts $63,800 to $133,700
Minnesota $63,800 to $125,600
New York/New Jersey $59,100 to $145,400
Washington $68,000 to $133,700
Requesting an Accommodation
Accenture is committed to providing equal employment opportunities for persons with disabilities or religious observances, including reasonable accommodation when needed. If you are hired by Accenture and require accommodation to perform the essential functions of your role, you will be asked to participate in our reasonable accommodation process. Accommodations made to facilitate the recruiting process are not a guarantee of future or continued accommodations once hired.
If you would like to be considered for employment opportunities with Accenture and have accommodation needs such as for a disability or religious observance, please call us toll free at **************** or send us an email or speak with your recruiter.
Equal Employment Opportunity Statement
We believe that no one should be discriminated against because of their differences. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities.
For details, view a copy of the Accenture Equal Opportunity Statement (********************************************************************************************************************************************
Accenture is an EEO and Affirmative Action Employer of Veterans/Individuals with Disabilities.
Accenture is committed to providing veteran employment opportunities to our service men and women.
Other Employment Statements
Applicants for employment in the US must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States.
Candidates who are currently employed by a client of Accenture or an affiliated Accenture business may not be eligible for consideration.
Job candidates will not be obligated to disclose sealed or expunged records of conviction or arrest as part of the hiring process. Further, at Accenture a criminal conviction history is not an absolute bar to employment.
The Company will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. Additionally, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the Company's legal duty to furnish information.
California requires additional notifications for applicants and employees. If you are a California resident, live in or plan to work from Los Angeles County upon being hired for this position, please click here for additional important information.
Please read Accenture's Recruiting and Hiring Statement for more information on how we process your data during the Recruiting and Hiring process.
$68k-133.7k yearly 60d+ ago
Socialite - Sports & Social Cary
Live! Hospitality & Entertainment
Editor job in Cary, NC
Job Responsibilities include, but are not limited to:
Use personality and wit to engage guests and build a loyal following for Sports & Social.
Maintain professional appearance standards as directed in the Live! Hospitality Employee Handbook.
Promote upcoming specials, activations, and events to encourage repeat guest visits.
Participate in off-site activations with local sports and community partners to generate an external buzz about the venue and increase guest traffic.
Partner with venue's promotions manager to support data collection and sales building programs.
Initiate conversations with guests about sports, current events, or their day to contribute to the social atmosphere of the venue.
Organize and lead trivia nights, pub quizzes, and simple bar games to create friendly competition and energize the crowd.
Organize and lead fun photo opportunities with branded elements, and host social media contests, encouraging guest interaction.
Write and develop new, catchy cheers relevant to games/events and encourage guests to learn and participate.
Write funny or catchy phrases for branded signage to be used during events to boost energy and enthusiasm.
Demonstrate superior knowledge of the Sports & Social brand and the entire Live! Hospitality & Entertainment estate.
Possesse in-depth knowledge of Sports & Social's food and beverage menu.
Serve all alcoholic beverages in accordance with all state regulations and alcohol awareness training standards.
Follow all company procedures when providing bottle service.
Accurately enter all drink orders into the POS system.
Follow supervisor's instructions, work as part of a team and help provide support to all team members.
Attend and participate in any training sessions or departmental meetings.
Qualifications:
Engaging, outgoing, and hospitable. Able to communicate comfortably with a diverse range of guests.
Portrays a positive and professional attitude.
Understands and follows professional and collegiate sports.
Follows current events and social trends.
Has knowledge of liquor brands, beer, wine, and non-alcoholic beverages, designated glassware, preparation methods and garnishments preferred.
Must meet state legal age requirements.
Alcohol awareness certification and/or food service permit or valid health/food handler card as required by local or state government agency.
Able to perform basic math to handle guest payment.
Able to work nights, weekends, and holidays.
Prior experience dancing or cheering in public preferred.
Prior experience in pop or country vocal performance an added bonus.
This is not necessarily an exhaustive list of all responsibilities, requirements or working conditions associated with the job. Live! Hospitality & Entertainment reserves the right to make changes in the above job description and all other duties assigned. Nothing herein shall restrict Live! Hospitality & Entertainment management's right to assign or reassign tasks, duties, or responsibilities to this job at any time.
$34k-54k yearly est. 60d+ ago
Senior/Principal Medical Writer - USA
Trilogy Writing and Consulting
Editor job in Durham, NC
Trilogy Writing & Consulting, an Indegene Company, is hiring
Senior/Principal Medical Writers
(USA)
to support our growing company in producing regulatory documentation for the international pharmaceutical industry. At Trilogy, you will play a pivotal role in delivering comprehensive services to our clients that extend beyond writing. Our writers are integral members of clinical development teams supporting the writing and coordination of successful documentation across a broad spectrum of therapeutic areas. As our company continues to expand, there is room to develop with us, and your ideas will form our future together. For further insight into who we are and what we do, please explore our website (************************
If this excites you, then apply below.
Applicants must live in the USA and be authorized to work for any employer in the USA (we are unable to sponsor or take over sponsorship of an employment visa at this time); may work either fully remotely or a hybrid schedule (in office/remote) from our Durham, NC, USA office.
You will be responsible for:
Preparing a variety of clinical regulatory documents (Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs, scientific publications) as the lead writer in collaboration with members of client authoring teams and supported by other writers, as appropriate.
Ensuring that all documents are produced according to agreed timelines, monitor and manage project budgets, adhere to relevant SOPs, and meet the requirements of Trilogy as well as the company's clients.
Providing document-specific advice to clients.
Overseeing and coordinating other writers and QC specialists assisting on documents under your responsibility.
Project managing the timelines and review cycles of your documents.
Working in the client's regulatory document management systems.
Your impact:
As a Senior/Principal Medical Writer, you will:
Function as a lead writer to prepare a variety of clinical regulatory documents (Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs, scientific publications) in collaboration with members of client authoring teams and supported by other writers, as appropriate.
Ensure that all documents are produced according to agreed timelines, monitor and manage project budgets, adhere to relevant SOPs, and meet the requirements of Trilogy as well as the company's clients.
Be responsible for providing document-specific advice to clients.
Oversee and coordinate other writers and QC specialists assisting with documents under your responsibility.
Project manage the timelines and review cycles of your documents.
Work in the client's regulatory document management systems.
Qualified applicants must have:
A minimum of a Bachelor's degree in science/pharmacy (Ph.D. not necessary).
Fluent written and spoken English skills.
A minimum of 3-5 years of experience of actively writing regulatory documents; experience as a lead writer on CTD documents is required for Principal Medical Writer.
Must have worked as the lead writer on key regulatory document(s) such as:
Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs, scientific publications.
For Principal Medical Writer, must have experience as the lead writer with multiple-document projects with global, multinational teams, including team management, project management, review management, and budget oversight.
Must be able to manage multiple projects simultaneously.
Experience interacting directly with clients or authors of the documents and coordinating review cycles, meetings, and project timelines.
Must have in-depth working knowledge of the relevant regulatory guidance (e.g. ICH, FDA, EMA) for clinical trial conduct, including document-specific guidance.
For Principal Medical Writer, Experience in multiple therapeutic areas to have confidence to work in these areas without lead-in time.
Competency in the use of document management systems and review tools.
Experience interacting directly with clients or authors of the documents and coordinating review cycles, meetings, and project timelines.
For the Principal Medical Writer level, ability and willingness to take on any project for which a Lead Writer is needed.
Competency in the use of document management systems and review tools.
An appreciation for a well-written document and an eye for details.
Excellent, proven interpersonal skills, and enjoy proactively participating on a team with diverse personalities.
Flexibility and the ability to stay focused under tight timelines.
Perks:
Competitive base salary (range: $120,000 to $159,000 USD; the salary range is an estimate and may vary based on experience level, region, and the Company's compensation practices)
Annual bonus opportunity
A generous allowance of paid time off (vacation, holiday, birthday, illness).
Comprehensive benefit plans to include medical, dental, vision, disability, life insurance with AD&D.
401K retirement savings plan with company match
Full AMWA membership and annual conference attendance paid for by Trilogy
Continuous personal and professional development opportunities
Free weekly yoga sessions
Other fun and exciting events that encourage team bonding and development
EQUAL OPPORTUNITY
Trilogy Writing & Consulting, an Indegene Company, is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, candidate's merit and qualification.
We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.
$120k-159k yearly 60d+ ago
G/FORE Copywriter
Petermillarllc
Editor job in Raleigh, NC
It's fun to work in a company where people truly BELIEVE in what they're doing!
We're committed to bringing passion and customer focus to the business.
This position will be tasked with writing creative, engaging, and informative marketing product copy. This role works in a collaborative team environment and must be highly detailed, possess exemplary writing skills, and have an eye for consistency. This position will assist with maintaining the G/FORE brand voice through every task. This is a fast-paced position with both calendared needs as well as spontaneous; a sense of urgency is important.
ESSENTIAL FUNCTIONS:
Create and write informative copy for web product descriptions, landing pages, internal knowledge documents, press releases, etc. as well as creative branding copy for launches, paid and organic social, emails, etc.
Collaborate effectively with E-Commerce, Marketing, Production, and Design teams for accurate and on-brand language.
Interpret and execute branded content as described by senior team members.
Support department managers with ongoing strategic projects and campaigns.
Maintain and organize a brand copy standard guide for the team to reference for consistency.
Assist in copywriting and editing for all catalogs, linesheets, etc. including naming all products with the apparel and footwear design teams.
COMPETENCIES:
Strong writing, editing, and proofreading skills.
The ability to mold your voice to that of the brand.
Proficiency in MS Office including Teams, Word, PowerPoint, and Excel; basic copyediting in Photoshop, Illustrator and InDesign is a plus.
Strong organization and time management skills.
Knowledge of SEO and best practices.
Fashion/apparel and/or golf experience a huge plus.
DESIRED EDUCATION AND EXPERIENCE:
A Bachelor's degree in Journalism, Advertising, Communications, Marketing or a related field preferred.
4+ years of copywriting experience; equivalent combination of education and experience will also be considered.
Portfolio of work that shows experience and abilities in copywriting for brands with an emphasis on product descriptions and advertisements.
If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!
$40k-70k yearly est. Auto-Apply 5d ago
Senior Medical Writer- FSP
Parexel 4.5
Editor job in Raleigh, NC
The Senior Medical Writer will research, create, and edit all documents associated with clinical research. The Senior Medical Writer may operate as the project lead writer/submission coordinator and primary client contact to manage contributions of multiple writers working on related documents. The Senior Medical Writer also facilitates process improvement and technical mentoring/training and supports Medical Writing Services management during the sales process by providing client liaison and proposals input.
**Key Accountabilities** :
**Author Clinical Documents**
+ Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize key clinical documents for submission to regulatory authorities, without the need for any supervision or additional formal on-the-job training. Train self and provide guidance to others to prepare any type of medical writing deliverable.
+ Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input.
+ Manage ongoing and/or revised project documentation and correspondence.
**Quality Control**
+ Ensure that all work is complete and of high quality prior to team distribution or shipment to client.
+ Provide technical leadership to ensure clinical data presented in summary documents is in compliance with applicable regulatory guidelines, SOPs, and goals of submission.
**Project Management**
+ Operate as the project lead writer/submission coordinator and primary client contact to manage contributions of multiple writers working on related documents. Manage scope of work, timeline and project goals, technical information, and input from clients throughout the project.
+ Develop, coordinate, and oversee work plans for individual and multiple-document delivery, to enable the team to work efficiently and effectively to meet milestones and achieve team objectives.
+ Provide leadership and strategic planning/adjustments, delegation of responsibilities, and tasks to team members. Monitor the progress of each individual project task and assess the overall program.
+ Ensure key information received in project or program meetings is appropriately disseminated, such that project strategy is maintained and data or key message changes are incorporated appropriately across documents.
+ Continuously monitor overall project performance and, if necessary, identify ways to ensure that the project is completed on-time and within budget.
+ Keep client and team informed of project status.
+ Contribute expertise as a document/cross-document specialist and content historian to analyze proposed program, studies, and related documents to deliver information required by the target audiences.
+ Build and maintain collaborative relationships with teams/clients, leading to increased performance and a sense of inclusion. Cultivate efficient, productive, and professional working relationships to promote client satisfaction and confidence.
+ Track actual versus planned project budget. Determine the cause of cost overruns and out-of-scope activities and recommend corrective action to medical writing management.
+ Provide updates for each project to Medical Writing Services management, and assess forecasting and resourcing. Propose creative solutions to medical writing management to shifting timelines and staffing requirements.
+ Communicate to writer's line manager any needs or concerns regarding level of training or performance of team members on project work. Provide line manager with input regarding team member's performance for employees' periodic performance review, and as needed.
**Client** **Liaison/Service**
+ Be aware of client expectations for self and team members. Respond appropriately to incidents of dissatisfaction, and feed back to Medical Writing Services management.
+ Provide support as appropriate to Business Development/Client Solutions and Medical Writing Services management in their efforts to win new business. Identify and solicit new business leads for Medical Writing Services, attend business development meetings, and prepare and make sales presentations to clients, if called upon.
+ Provide strategic and project planning intelligence to Medical Writing Services management for medical writing activities in the proposal generation process, including assessment of scope of services to be provided to a client with respect to medical writing tasks. May attend proposal development meetings if requested by Medical Writing Services management.
+ Input to development of client proposals generated by Medical Writing Services and letters of agreement/intent based on existing templates. May function as the client contact if requested and communicate pricing information in conjunction with Medical Writing Services management.
+ If requested, suggest appropriate resourcing, based on existing templates and standards, for full-service and stand-alone projects.
**Training/Compliance**
+ Keep abreast of new advances in medical writing and regulatory issues.
+ Develop and train Medical Writing Services staff to enhance writing quality, efficiency, and project management.
+ Implement and monitor departmental compliance to SOPs. Input to development or revision of departmental SOPs, as appropriate.
+ Develop and present external training courses.
**General**
+ Attend departmental and company meetings as necessary.
+ Comply with departmental procedures and requirements, such as completion of project assignment and workload trackers on the applicable software platform
+ Analyze efficiency of work and discuss improvement ideas with Medical Writing
+ Services management and colleagues, e.g., evaluation of software to increase productivity and document quality.
**Skills:**
+ Excellent interpersonal, negotiation, verbal, and written communication skills.
+ A flexible attitude with respect to work assignments and new learning.
+ Motivation to work consistently in a fast-paced, rapidly changing environment.
+ Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail, e.g., organizational skills.
+ Competent working in a matrix environment and values the importance of teamwork. Possesses team leadership skills and cross-cultural sensitivity.
+ Exhibits sound judgement: escalates issues to project teams or departmental management as appropriate. Presents solutions and follows through to ensure problems have been satisfactorily resolved.
+ Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectations are aligned.
+ Understands and satisfies client needs.
+ Establishes a connection with the client beyond one's project, to gain repeat business and/or to widen existing scope and services. Ability to gain trust and confidence within the company.
+ Provides departmental expertise and perspectives to promote prospective business opportunities; provide Parexel colleagues with pertinent information to formalize a sound business strategy.
**Knowledge and Experience** :
+ Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines and regulations.
+ Broad experience in preparation of all types of clinical regulatory documentation. Experience in management of complex medical writing projects.
+ Knowledge of resource management and productivity metric management.
+ Advanced word processing skills, including MS Office (expertise in Word); software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (Excel).
+ Ability to travel.
+ Fluent in written and spoken English.
**Education:**
+ Bachelor's degree in Life Sciences/Health Related Sciences or equivalent.
\#LI-KW1
\#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
$76k-112k yearly est. 36d ago
Principal Medical Writer (Consultant, Regulatory Submissions)
Propharma Group
Editor job in Raleigh, NC
For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs.
The Principal Medical Writer position is responsible for authoring medical writing deliverables with a focus on quality, accuracy, and efficiency, and provides medical writing support to ProPharma clients.
Essential Functions:
Ensures appropriate communication on project- and program-related matters with medical writing leadership, internal functional area heads, and internal resources/consultants as applicable.
Manages clinical program documents for assigned clients, such as protocols, protocol amendments, IBs, ICFs, patient narratives, study reports, as well as more complex regulatory documents (e.g., PBRER, IND, NDA, BLA, MAA, eCTD submissionlevel documents) as assigned.
Leads cross-functional coordination of resources (e.g., internal resources/consultants) to manage medical writing and QC deliverables as assigned.
Independently authors (writes/edits) high-quality medical writing deliverables (i.e., clinical, safety, regulatory, device, diagnostics, or disclosures documents) across all phases of clinical research and in various therapeutic areas including but not limited to: protocols, protocol amendments, study reports, patient narratives, IBs, ICFs, CEPs/CERs, DSURs, and plain language summaries, as well as more complex documents (e.g., PBRER, IND, NDA, BLA, MAA, eCTD submission level documents).
Supervises, trains, and mentors less experienced medical writers, as necessary.
Adheres to established regulatory standards/guidelines including but not limited to: ICH E3 or E6(R2), EU MDR/IVDR, Company standard operating procedures, client standards, and Company- and/or client-approved templates.
Strives to complete medical writing deliverables on time and within budget.
Independently manages client expectations and interacts and communicates directly with clients, leads team meetings (e.g., project kickoff, comment review), and manages the deliverable timelines.
Interacts and collaborates with subject matter experts in clinical operations, data management, biostatistics, regulatory affairs, etc., as needed, to produce medical writing deliverables.
Coordinates QC reviews of documents and maintains audit trails of changes as applicable.
Reviews statistical analysis plans and table/figure/listing shells (as applicable) for appropriate content, grammar, format, and consistency.
If requested by supervisor, performs QC review (e.g., reviews in-text tables against statistical output).
Performs peer review of documents written by other medical writers, as .
Assists with project-related administrative tasks (e.g., creates and maintains timelines, updates deliverable trackers, hosts internal/client meetings).
Maintains familiarity with current industry practices, regulatory requirements, and guidelines related to medical writing.
Understands budget specifications for assigned deliverables, works within the budgeted hours, and communicates out-of-scope tasks to medical writing leadership.
Supports multiple medical writing deliverables/projects simultaneously and manages own workload with minimal intervention from management team.
Brings issues and potential concerns to line manager/client oversight manager's attention and proposes possible solutions for consideration by management team.
Participates in and leads departmental initiatives (e.g., process improvement, lunch and learns, etc.).
Other duties as assigned.
Necessary Skills and Abilities:
Advanced knowledge of clinical research principles and demonstrated ability to interpret and present clinical data and other complex information.
Advanced understanding of FDA (and other regulatory bodies as relevant to their role) and applicable regulations and guidelines.
Advanced understanding of regulatory submission requirements and processes.
Computer technology proficiency and expert word processing skills in MS Word, including required proficiency with tables, graphs, and figures.
Exceptional project management skills and strong communication skills with a high attention to detail and quality.
English language proficiency and familiarity with American Medical Association (AMA) style.
Strong experience in relationship building and strategic collaboration on key business accounts.
Thinks proactively, takes initiative, and willingly takes on new challenges.
Ability to identify areas of concern or inefficiency and propose solutions for consideration by the management team to improve overall efficiency and quality of deliverables.
Works independently with exceptional time-management skills and contacts management team proactively when additional support and resources are needed.
Works effectively in a collaborative team environment.
Demonstrates a growth mindset and positive outlook in all work activities.
Educational Requirements:
Bachelor's degree or higher, preferably in medical or scientific discipline.
Experience Requirements:
Minimum of 7 years of experience in writing clinical and/or regulatory documents for drugs, biologics, and/or medical devices/diagnostics for a contract research organization, pharmaceutical company, or biotechnology company.
Other professional and/or educational experience may contribute toward this minimum requirement, as determined on a casebycase basis.
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
$71k-105k yearly est. Auto-Apply 39d ago
Need Test Scripts Writer at $32/hr
Us It Solutions 3.9
Editor job in Durham, NC
This is Priya Sharma from US IT solutions Inc. and we are Staffing Specialist working directly with all US States and Local and Commercial clients. We are known for our IT Services, Mobile development, Web development and Cloud computing and working with clients to deliver high-performance results.
This is Priya Sharma from US IT solutions Inc. and we are Staffing Specialist working directly with all US States and Local and Commercial clients. We are known for our IT Services, Mobile development, Web development and Cloud computing and working with clients to deliver high-performance results.
If interested, Kindly call me on 408-766-00
-
00 Ext 431
Job Description
Experience and proficiency in using HP test tools including Test Director/Quality Center 9.0 or higher and Quick Test Professional (QTP) 9.5 or higher
Experience testing web, GUI, client/server, and database applications.
Experience with requirements analysis and automated test cases/script development.
Experience with manual or automated testing, testing tools, writing test plans and reviewing test cases.
Qualifications
Duties include analyzing business requirements for testability and completeness using Functional Specification Documents, Business Requirements Documents and Technical Design Documents, developing requirements into test conditions, cases and scripts, development and execution of automated scripts using HP Quality Center to thoroughly test software to ensure proper operation and freedom from defects. This position is responsible for reviewing test cases and other testing artifacts to ensure the accuracy and completeness of all test artifacts. This position coordinates testing, reports and tracks testing problems by providing reproducible test cases, works with other product team members to diagnose and recreate problems as well as prioritize and implement solutions and close problem reports. This position is responsible for test scripting data collection and analysis according to the project plan schedule and ensuring adherence to standard practices and procedures.
Additional Information
Thanks & Regards
Priya Sharma
************ Ext 431
$75k-100k yearly est. 60d+ ago
Principal Medical Writer - Regulatory Submission Documents
Syneos Health, Inc.
Editor job in Morrisville, NC
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health
* We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
* We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
* We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.
Job Responsibilities
* Lead the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately
* Manage medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision
* Complete a variety of documents, including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, and abstracts, posters, and presentations for scientific meetings
* Adhere to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guides
* Coordinate quality and editorial reviews, ensuring source documentation is managed appropriately
* Act as a peer reviewer for the internal team to ensure document scientific content, clarity, overall consistency, and proper format
* Review statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency, providing feedback to further define statistical output required and document needs
* Interact and build good working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs to produce writing deliverables
* Perform online clinical literature searches and comply with copyright requirements
* Identify and propose solutions to resolve issues, providing technical support, training, and consultation to department and other company staff
* Mentor and lead less experienced medical writers on complex projects
* Develop deep expertise on key topics in the industry and regulatory requirements
* Work within budget specifications for assigned projects
Qualifications:
* Bachelor's degree in a relevant discipline with relevant writing experience; graduate degree preferred
* 3-5 years of relevant experience in science, technical, or medical writing
* Experience working in the biopharmaceutical, device, or contract research organization industry required
* Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required
* Experience writing relevant document types required
* Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style
Necessary Skills:
* Strong presentation, proofreading, collaborative, and interpersonal skills
* Strong project and time management skills
* Strong proficiency in MS Office
* Strong understanding of medical terminology, principles of clinical research, and how to interpret and present clinical data and other complex information
At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.
Salary Range:
$80,600.00 - $145,000.00
The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
***************************
Additional Information
Tasks, duties, and responsibilities as listed in this are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Summary
Roles within the Medical Writing job family at the P22 level are responsible for writing and editing manuscripts and other medical communications on clinical studies and scientific reports. This includes special summaries from raw data for submission to regulatory agencies or for in-company use, monographs, comprehensive reviews, scientific exhibits, and other projects requiring skill in medical communication. The role involves screening, analyzing, and summarizing additional data from other sources as needed, conducting systematic literature searches and reviews, preparing literature for new products, and revising existing medical communication. These roles review and analyze statistical outputs to prepare results-based documents such as clinical study reports and development safety update reports. They support engagement and interaction with regulatory agencies through the preparation of briefing books and response documents to health authority questions. They may be responsible for entire projects or processes within their area of responsibility. Impact and Contribution Roles within the Medical Writing job family at the P22 level play a crucial role in ensuring the clear and accurate completion of medical writing deliverables, presenting scientific information clearly and accurately. They manage medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision. These roles lead the resolution of comments from clients and complete a variety of documents, including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, and abstracts, posters, and presentations for scientific meetings. They adhere to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guides. These roles coordinate quality and editorial reviews, ensure source documentation is managed appropriately, and act as peer reviewers for the internal team to ensure document scientific content, clarity, overall consistency, and proper format. Core Focus • Leading the clear and accurate completion of medical writing deliverables • Managing medical writing activities associated with individual studies • Coordinating these activities within and across departments • Completing a variety of documents, adhering to established regulatory standards • Coordinating quality and editorial reviews • Acting as peer reviewers for the internal team • Reviewing statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency • Interacting and building good working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs • Performing online clinical literature searches and complying with copyright requirements • Identifying and proposing solutions to resolve issues, providing technical support, training, and consultation to department and other company staff • Mentoring and leading less experienced medical writers on complex projects • Developing deep expertise on key topics in the industry and regulatory requirements • Working within budget specifications for assigned projects
$80.6k-145k yearly 42d ago
Reporter I, MultiMedia Journalist
Tribune Broadcasting Company II 4.1
Editor job in Raleigh, NC
WNCN-TV/CBS 17, the Nexstar station in Raleigh, is looking for the next Multimedia Journalist. We are looking for someone who is self-sufficient, proactive and aggressive covering breaking news. We want someone who can generate enterprise stories, build sources, and emerge themselves in a community. The job requires the ability to listen to and respond to police scanners, shoot, write, edit and report from the scene of breaking news and cover general assignment news in a manner that is clear, engaging and meaningful to news consumers.
Reports news stories for broadcast, describing the background and details of events
Arranges interviews with people who can provide information about stories
Reviews copy and corrects errors in content, grammar and punctuation, following prescribed editorial style and formatting guidelines
Reviews and evaluates notes taken about event aspects to isolate pertinent facts and details
Determines a story's emphasis, length and format, and organizes material accordingly
Researches and analyzes background information related to news stories to be able to provide complete and accurate information
Gathers information about events through research, interviews, experience or attendance at political, news, sports, artistic, social or other functions
Pitches stories to news managers and news producers which are relevant to the local community
Receives assignments and evaluates leads and tips to develop story ideas
Discusses issues with producers and/or news managers to establish priorities or positions
Checks reference materials such as books, news files or public records to obtain relevant facts
Revises work to meet editorial approval or to fit time requirements
Shoots and edits news events and news reports
Produces and presents reports for all platforms
Ensures that all content meets company standards for journalistic integrity and production quality
Writes stories for the web and other eMedia platforms
Interacts with viewers/users on social media sites
Performs special projects and other duties as assigned
Requirements & Skills:
Bachelor's degree in Broadcast Journalism, or a related field, or an equivalent combination of education and work-related experience
Excellent communication skills, both oral and written with the ability to
ad lib
when required
Minimum two years' experience in news reporting (Depending on market size)
Engaging on-air presence
Proactive in responding to breaking news across the Raleigh-Durham market
Ability to gather urgent information on-scene from witnesses and law enforcement
Ability to shoot, write and edit using various technology
Produce content for all platforms
Ensure that all content meets company standards for journalistic integrity and production quality
Interact with viewers/users on social media sites
Perform special projects and other duties as assigned
Valid driver's license with a good driving record
Flexibility to work any shift
$32k-45k yearly est. Auto-Apply 13d ago
Multi-Media Interns Wanted For Coastal Plain League Teams - Huge Portfolio Building Opportunity!
Coastal Plain League
Editor job in Holly Springs, NC
The Coastal Plain League is the nation's premier summer collegiate baseball league. Set to begin its 22nd season in 2018, the CPL features 16 teams playing in Georgia, North Carolina, South Carolina and Virginia. The CPL has had over 1,400 alumni drafted and 109 of those - including 2011 AL MVP and Cy Young winner Justin Verlander - make their Major League debut; while another notable alum - Russell Wilson - won Super Bowl XLVIII. For more information on the Coastal Plain League, please visit the league website at *************************** and follow us via Twitter @CPLBaseball
Job Description
Start Date: Mid-May 2018
End Date: Mid-August 2018
Academic Qualifications: Prefer Communication, Design, Media, etc. fields of study, but will consider other qualified applicants.
Desired Skills and Qualifications:
• Familiar with social media platforms (specifically Instagram & SnapChat) and the proper etiquette required in a professional setting.
• Video editing is a plus but not required
• Must have your own device to shoot video, pictures, post, etc. from. Many schools have rented these out to interns in the past. Phones are acceptable if high quality and you accept data responsibilities.
• Computer savvy, comfortable with Microsoft Word, Photoshop, or any graphic design program
• Responsible enough to work alone
• Knowledge of baseball a plus
Description and Responsibilities:
Each intern will be assigned to one of our 16 franchises (across four states) and be responsible for posting to the league's SnapChat and Instagram accounts for each home game. They will also be asked to collect video, pictures and more of the players for our media database. Their work will be featured in articles as well as the league's Around the CPL weekly show.
Interns will have the opportunity to pitch their own story ideas, whether print or digital based, throughout the summer as well as taking part in league wide video initiatives (i.e. Memorial Day, Fourth of July, Father's Day, etc.)
Overall we feel this internship offers students the rare opportunity to build their portfolio in an impactful manner. It also allows them to be apart of the most entertaining league in the country - no pressure.
(Travel to road games is NOT required. Working all home games is a MUST)
Compensation: Meal stipend for each home game worked. Local housing where available for interns outside of the team's geographic footprint.
Credit: College credit towards a major, minor, or general elective is welcomed.
Team Locations:
Asheboro Copperheads - Asheboro, N.C.
Edenton Steamers - Edenton, N.C.
Fayetteville SwampDogs - Fayetteville, N.C.
Florence RedWolves - Florence, S.C.
Forest City Owls - Forest City, N.C.
Gastonia Grizzlies - Gastonia, N.C.
High Point-Thomasville, HiToms - Thomasville, N.C.
Holly Springs Salamanders - Holly Springs, N.C.
Lexington County Blowfish - Lexington, S.C.
Macon Bacon - Macon, Ga.
Martinsville Mustangs, Martinsville, Va.
Morehead City Marlins - Morehead City, N.C.
Peninsula Pilots - Peninsula, Va.
Savannah Bananas - Savannah, Ga.
Wilmington Sharks - Wilmington, N.C.
Wilson Tobs - Wilson, N.C.
-Housing potentially available in some places but any interns from out of the area are not guaranteed free housing.
Qualifications
Academic Qualifications: Prefer Communication, Design, Media, etc. fields of study, but will consider other qualified applicants.
Desired Skills and Qualifications:
• Familiar with social media platforms (specifically Instagram & SnapChat) and the proper etiquette required in a professional setting.
• Video editing is a plus but not required
• Must have your own device to shoot video, pictures, post, etc. from. Many schools have rented these out to interns in the past. Phones are acceptable if high quality and you accept data responsibilities.
• Computer savvy, comfortable with Microsoft Word, Photoshop, or any graphic design program
• Responsible enough to work alone
• Knowledge of baseball a plus
Additional Information
All your information will be kept confidential according to EEO guidelines.
$21k-29k yearly est. 60d+ ago
Test Scripts Writer
Infojini 3.7
Editor job in Durham, NC
Infojini Consulting is a full service IT consulting, services, and staffing firm with offices in Secaucus, NJ.
Infojini Consulting is recognized as one of the fastest growing IT services and software development Companies. With a partnership of all major technology vendors, Infojini Consulting has built a strong Government and commercial customer base including fortune 100 companies and most state and federal agencies such as State of North Carolina, State of South Carolina, State of Maryland, State of California, State of Pennsylvania, State of Virginia, State of Washington and many others.
Infojini Consulting is an equal opportunity employer and considers all qualified individuals for employment irrespective of their race, gender, age, color, sexual orientation. We offer an excellent compensation package
Job Description
We are looking for Test Scripts Writer in Durham, NC for 6+ months contract position.
Please refer someone else if you are not available at this time or you are not right match for this job opportunity. We have great Referral Bonus up to $2500!!! Please don't miss to refer someone who are looking for projects.
Job details mentioned below
Title: Test Scripts Writer
Duration: 6+ Months
Location: Durham, NC
Rate: $33/hr on c2c
Required:
Experience and proficiency in using HP test tools including Test Director/Quality Center 9.0 or higher and Quick Test Professional (QTP) 9.5 or higher
Experience testing web, GUI, client/server, and database applications.
Experience with requirements analysis and automated test cases/script development.
Experience with manual or automated testing, testing tools, writing test plans and reviewing test cases.
Strong analytical and problem solving skills.
Good oral and written communications skills in order to interact on a daily basis with system developers, business analysts, and others.
Ability to prioritize tasks within the project and work with minimal supervision or guidance.
Ability to work in a rapidly changing environment.
Stable work history
Preferred:
Experience with testing Curam products.
Experience testing for a health and human services project.
Experience with executing SQL to validate or test.
Experience navigating on a UNIX platform.
Experience developing and executing Selenium automation test scripts.
Additional Information
All your information will be kept confidential according to EEO guidelines.
$33 hourly 60d+ ago
Test Scripts Writer
Ask It Consulting
Editor job in Durham, NC
NC FAST P4 Test Scripts Writer
Duration :12 + Months
Rate : $28/hr on C2C
Short Description: NC FAST requires the services of 2 Test Scripts Writers to support development and implementation of NC FAST Project 4 modules.
Complete Description:
The NC Department of Health and Human Services seeks contractor resources to assist with the development and implementation of NC Families Accessing Services through Technology (NC FAST) as a Test Scripts Writer. Duties include analyzing business requirements for testability and completeness using Functional Specification Documents, Business Requirements Documents and Technical Design Documents, developing requirements into test conditions, cases and scripts, development and execution of automated scripts using HP Quality Center to thoroughly test software to ensure proper operation and freedom from defects. This position is responsible for reviewing test cases and other testing artifacts to ensure the accuracy and completeness of all test artifacts. This position coordinates testing, reports and tracks testing problems by providing reproducible test cases, works with other product team members to diagnose and recreate problems as well as prioritize and implement solutions and close problem reports. This position is responsible for test scripting data collection and analysis according to the project plan schedule and ensuring adherence to standard practices and procedures.
Additional Information
All your information will be kept confidential according to EEO guidelines.
$28 hourly 60d+ ago
Grant and Budget Specialist
Nc State University 4.0
Editor job in Raleigh, NC
Preferred Qualifications Prior knowledge of post-award grant administration and budget practices Must be capable of working independently as well as part of a team Work Schedule Monday -Friday , 8:00 am- 5:00 pm
**LOCATION:** U.S. locations - remote/hybrid. Candidates within commuting distance of a Wolters Kluwer office will be considered for hybrid employment. Candidates not within commuting distances will be considered for remote employment. The **Physician Editor (Endocrinology)** position requires an 80 to 90% FTE commitment for editorial work, a broad understanding of clinical issues, and an interest in analyzing the literature. For the right person, this is a unique opportunity to impact the practice of medicine throughout the United States and around the world. Physician Editors ensure that topics address the important clinical questions that arise when diagnosing or managing a specific disorder, present information clearly and succinctly, and provide evidence-based and actionable recommendations for care. Extensive editorial training is provided to help the editor learn critical skills for evaluating the literature and creating content in the UpToDate style. Training is overseen by at least two senior Physician Editors. All new topics are read and reviewed by the training editors until the new Physician Editor achieves a satisfactory level of independence.
You will be trained remotely and can work from anywhere in the United States. However, work hours should significantly overlap with standard work hours in the Eastern time zone to allow for regular interaction with other Physician Editors. Candidates with strong academic backgrounds are of particular interest. Editing requires 80 to 90% FTE. In the remaining 10 to 20% time, Physician Editors should remain involved in patient care activities, using their clinical experience to help ensure the content of the program is maximally useful at the point of care. Thus, the position provides the opportunity to remain clinically active while spending most of your time crafting clear content, reviewing the literature, and discussing the impact of new research on clinical practice with our expert contributors.
**ESSENTIAL DUTIES & RESPONSIBILITIES:**
Our physician editors review and edit the new contributions from our external expert authors to make sure they address the questions that a practicing clinician might have. Topics must contain specific and actionable recommendations and describe the supporting evidence. Updating is an equally important component of the work and is usually initiated by the Physician Editor, who is responsible for monitoring the literature for new developments and identifying topics that need updating. Physician Editors also systematically review existing topics for clarity, completeness, and clinical relevance. This work is not done in isolation. UpToDate editors work closely with outside authors, section editors, editors-in-chief, and peer reviewers to ensure the material is accurate and free of bias. In addition, in-house editorial and graphics assistants work with the Physician Editors to produce and maintain each topic.
**QUALIFICATIONS**
**Required Education:**
+ Medical Degree
+ Board Certification/Eligibility in Adult Endocrinology
**Preferred Experience, Knowledge, and Abilities:**
+ Clinical experience in an academic setting after residency
+ A valid medical license in at least on U.S. state
+ Impeccable communication skills: verbal, writing, and listening
+ Ability to work collaboratively with colleagues at different skill levels
+ Self-motivated, with excellent organizational and time management skills
+ Ability to give and receive feedback effectively
+ Interest in critical analysis of the medical literature (skills can be learned on the job)
+ Ability to spend 80 to 90% of the work week on editorial work
+ Interest in and ability to maintain clinical work (10 to 20%)
**TRAVEL:** Minimal - less than 5%
**UpToDate (******************* is an electronic clinical decision support resource for physicians and patients that provides current medical information in a format accessible via computer, smartphone, or tablet. **UpToDate is part of Wolters Kluwer Health** , an international corporation that provides tools to assist professionals in health care, finance, and accounting. More than 850,000 clinicians in 164 countries and more than 90% of academic medical centers in the United States rely on UpToDate. Over 60 research studies confirm UpToDate's widespread usage and association with improved patient care and hospital performance, including reductions in length of stay, adverse complications, and mortality.
\#LI-remote
**Our Interview Practices**
_To maintain a fair and genuine hiring process, we kindly ask that all candidates participate in interviews without the assistance of AI tools or external prompts. Our interview process is designed to assess your individual skills, experiences, and communication style. We value authenticity and want to ensure we're getting to know you-not a digital assistant. To help maintain this integrity, we ask to remove virtual backgrounds and include in-person interviews in our hiring process. Please note that use of AI-generated responses or third-party support during interviews will be grounds for disqualification from the recruitment process._
_Applicants may be required to appear onsite at a Wolters Kluwer office as part of the recruitment process._
**Compensation:**
$172,100.00 - $307,450.00 USD
This role is eligible for Bonus.
_Compensation range listed is based on primary location of the position. Actual base salary offer is influenced by a wide array of factors including but not limited to skills, experience and actual hiring location. Your recruiter can share more information about the specific offer for the job location during the hiring process._
**Additional Information** **:**
Wolters Kluwer offers a wide variety of competitive benefits and programs to help meet your needs and balance your work and personal life, including but not limited to: Medical, Dental, & Vision Plans, 401(k), FSA/HSA, Commuter Benefits, Tuition Assistance Plan, Vacation and Sick Time, and Paid Parental Leave. Full details of our benefits are available upon request.
EQUAL EMPLOYMENT OPPORTUNITY Wolters Kluwer U. S. Corporation and all of its subsidiaries, divisions and customer/business units is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
$46k-61k yearly est. 60d+ ago
Senior Copywriter
Accenture 4.7
Editor job in Raleigh, NC
We are: Accenture Song is the world's largest tech-powered creative group. We accelerate growth and value for our clients through sustained customer relevance. Our capabilities span ideation to execution: growth, product and experience design; technology and experience platforms; creative, media and marketing strategy; and campaign, content and channel orchestration. With strong client relationships and deep industry expertise, we help our clients operate at the speed of culture through the unlimited potential of creativity, technology and intelligence-both human and artificial. Visit us at: **********************
You are:
We are searching for a Senior Copywriter who is passionate about their craft and eager to make an impact on the work we do. This individual is experienced within the creative industry and is comfortable with multiple medias-from interactive, to brand campaign, and digital content and has worked with a variety of clients, tones and voice styles and will ensure exceptional results . This position needs someone who is confident as an individual contributor, ready to jump in and take a leadership role when required and embraces collaboration to deliver the best concept and solutions. Our ideal candidate has a substantial portfolio of published creative work and professional writing experience. This person must thrive in a fast-paced work environment and enjoy working on numerous projects at once. But above all, this candidate is a strong writer who can easily adapt to different styles.
The work:
* Write compelling and creative copy for a variety of platforms and lengths across the funnel-from big idea campaigns and TV spots to long form content eBooks and social media ads
* Demonstrate excellent oral and written communication skills
* Demonstrate excellent presentation skills; comfortable presenting and defending concepts and copy for both internal and client-facing meetings
* Deliver assignments on time while consistently meeting Accenture Song quality standards
* Demonstrate proficiency in copy style guidelines
* Understand and appreciate the importance of strategy
* Manage multiple clients and deliverables simultaneously with keen attention to craft and detail
* Handle all facets of production and post-production with minimal supervision
* Lead and own work, and formulate and develop disruptive ideas with minimal oversight or creative direction
* Lead and mentor junior copywriters and ensure Accenture Song quality standards in all copy deliverables
Qualification
Basic Qualifications:
* At least 4 years of copywriting experience (B2B or B2C)
* Minimum 2 of years agency or equivalent industry experience in the creative field across all media-including digital, social, film, longform content and print
* Portfolio or samples of work demonstrating smart, strategic, disruptive and/or brand-building concepts and executions across multiple platforms.
Bonus points if you have:
* Bachelor's degree in creative writing, journalism, advertising, marketing, or English
* Excellent presentation skills/public speaking
* Clear point of view on AI and the future of advertising
* Natural storytelling skills
* Ability to work and thrive in a highly collaborative environment with multidisciplinary cross-function teams.
* Expertise in strategic brainstorming and campaign development
* Experience in using GenAI as part of your workflow
* Experience with Telecomm, Media and Technology (CMT) industry clients
* Experience in scaled AOR engagements
* Portfolio includes award-winning, industry-acclaimed work for craft and creativity (OneShow, AD&D, Cannes, Webbys, Emmys, Andys, Effies, ADC)
* Fluent in social media platforms and trends
Compensation at Accenture varies depending on a wide array of factors, which may include but are not limited to the specific office location, role, skill set, and level of experience. As required by local law, Accenture provides a reasonable range of compensation for roles that may be hired as set forth below.
We accept applications on an on-going basis and there is no fixed deadline to apply.
Information on benefits is here.
Role Location Annual Salary Range
California $63,800 to $145,400
Cleveland $59,100 to $116,300
Colorado $63,800 to $125,600
District of Columbia $68,000 to $133,700
Illinois $59,100 to $125,600
Maryland $63,800 to $125,600
Massachusetts $63,800 to $133,700
Minnesota $63,800 to $125,600
New York/New Jersey $59,100 to $145,400
Washington $68,000 to $133,700
Locations
$68k-133.7k yearly 5d ago
Barback - Sports & Social Cary
Live! Hospitality & Entertainment
Editor job in Cary, NC
Sports & Social Cary is a one-of-a-kind sports bar and social lounge located in downtown Cary. The location will have plenty of TV screens for fans to watch games, outfitted with state-of-the-art AV technology, the space will boast an impressive LED display showing multiple games and sporting events at once. Sports & Social will offer guests an elevated dining and beverage experience including made-from-scratch menu items and curated cocktails, live music and special events several days a week, as well as a wide variet
Barback Responsibilities include, but are not limited to:
Show that you are an energetic, outgoing, fun person while maintaining professionalism.
Perform basic prep work behind the bar: refilling ice bins, restocking beer/liquor, cutting garnishes.
Change empty kegs in keg room, including moving full kegs of beer.
Assist in maintaining a clean and tidy environment by cleaning up spills and emptying trash cans.
Organizes bar and drink ware.
Clear and clean bar in a timely manner.
Perform more than one task at a time.
Offer polite, professional, and courteous customer service.
Communicate effectively, clearly, patiently and humorously with co-workers and guests.
Complete all side work as assigned.
Barback Qualifications
Food service experience with general knowledge of bar/nightclub operations.
Must speak fluent English, other languages preferred.
Must be at least age 18 or older, depending on state regulations.
Communication skills are utilized a significant amount of time when interacting with guests, cooks, wait staff, and supervisors.
Alcohol awareness certification and/or food service permit or valid health/food handler card as required by local or state government agency.
Reading and writing abilities are utilized often when taking orders, completing paperwork, etc.
Mathematical skills, including basic math are used frequently.
May be required to work nights, weekends, and/or holidays.
The Barback position requires the ability to perform the following:
Handling, carrying or lifting items weighing up to 200 pounds (kegs, ice, glasses, trays, etc.)
Move about the facility efficiently and safely.
Handling food, objects, products and utensils effectively and safely.
Bending, standing, stooping, kneeling
Withstand potential climate temperature changes in assigned work area.
y of interactive social games for everyone to enjoy.
$34k-54k yearly est. 60d+ ago
Test Scripts Writer
Us It Solutions 3.9
Editor job in Durham, NC
We are from US IT Solutions, an ISO Certified, E-Verify, WMBE Certified organization established in 2005 in CA. Our company is serving various State, Local and County Departments for over 10 years. USITSOL has been helping clients innovate across all phases of the application lifecycle for over a decade. Some of our prestigious clients are State of CA, State of OR, State of FL, State of NC, State of GA, State of CO, State of VA, State of AR, State of MI, State of OH, State of IL, State of MO, State of MS, California State University, Sacramento Area Sanitation Department, SMUD, Sound Transit, LA Superior Courts, District of Columbia, UMAS, University of Central Florida and Hennepin County and many more.
Job Description
Title/ Designation: Test Scripts Writer
Duration 12 Months
Location: Durham, NC
Description:
Duties include analyzing business requirements for test ability and completeness using Functional Specification Documents, Business Requirements Documents and Technical Design Documents, developing requirements into test conditions, cases and scripts, development and execution of automated scripts using HP Quality Center to thoroughly test software to ensure proper operation and freedom from defects.
This position is responsible for reviewing test cases and other testing artifacts to ensure the accuracy and completeness of all test artifacts. This position coordinates testing, reports and tracks testing problems by providing reproducible test cases, works with other product team members to diagnose and recreate problems as well as prioritize and implement solutions and close problem reports. This position is responsible for test scripting data collection and analysis according to the project plan schedule and ensuring adherence to standard practices and procedures
Qualifications
Skills:
Experience and proficiency in using HP test tools including Test Director/Quality Center 9.0 or higher and Quick Test Professional (QTP) 9.5 or higher
Experience testing web, GUI, client/server, and database applications.
Additional Information
Experience with requirements analysis and automated test cases/script development
Experience with manual or automated testing, testing tools, writing test plans and reviewing test cases.
$75k-100k yearly est. 60d+ ago
Principal Medical Writer - Narrative Documents
Syneos Health, Inc.
Editor job in Morrisville, NC
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health
* We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
* We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
* We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.
Job Responsibilities
* Leads the clear and accurate completion of complex medical writing deliverables, ensuring scientific information is presented clearly and accurately. Manages medical writing activities associated with individual studies, defining document strategy and coordinating medical writing activities within and across departments with minimal supervision. Leads the resolution of comments from the client.
* Completes a variety of documents that may include clinical study protocols and clinical study protocol amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consents; annual reports; plain language summaries; periodic safety update reports, clinical development plans; IND submissions; integrated summary reports; NDA and eCTD submissions; journal manuscripts; and abstracts, posters, and presentations for scientific meetings.
* Adheres to established regulatory standards, including, but not limited to, ICH E3 guidelines, as well as company standard operating procedures, client standards, and company and/or client approved-templates, authorship requirements, and style and formatting guides, when completing medical writing projects, on time and on budget.
* Advises clients and study teams on data presentation and production strategies to ensure that client objectives/expectations are met and quality standards are maintained.
* Leads team document reviews and reviews documents for technical issues. Coordinates quality and editorial reviews and ensures source documentation is managed appropriately.
* Serves as expert peer reviewer for internal team, providing review comments to give maximum clarity of meaning, accuracy, and relevance, and to ensure that client objectives are met and overall quality standards are maintained.
* Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency. Provides feedback to further define statistical output required and document needs.
* Interacts and builds good working relationships with clients, department head, and team members in data management, biostatistics, regulatory affairs, and medical affairs, as necessary, to produce writing deliverables. Works with staff across company to advance company priorities.
* Performs online clinical literature searches and complies with copyright requirements.
* Identifies and proposes solutions to resolve issues, escalating as appropriate. Serves as a key technical SME and contributes to development of internal materials and presentations on needed topics. Contributes to changes to internal process, standard practices, and capabilities.
* Mentors and leads less experienced medical writers on complex documents.
* Develops deep expertise on key topics in the industry and the regulatory requirements and guidelines that affect medical writing. Engages externally with industry groups on industry initiatives.
* Aware of budget specifications for assigned projects, communicating status and changes to medical writing leadership. Contributes to bid projections.
* Communicates status and changes to medical writing leadership; negotiates timelines and assigned deliverables.
* Represents the medical writing department on clinical study teams, at conferences, meetings, and for presentations to the client regarding writing projects.
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
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Additional Information
Tasks, duties, and responsibilities as listed in this are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Summary
Principal medical writer on clinical study or regulatory project teams. Provides scientific writing, regulatory guidance, and technical expertise in the writing, production, and review of high-quality complex regulatory and other scientific/clinical documents, ensuring that clinical data is presented in documents in compliance with applicable regulatory guidelines. May guide the work of junior writers.
The average editor in Raleigh, NC earns between $29,000 and $72,000 annually. This compares to the national average editor range of $34,000 to $78,000.